MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CONTINUUM SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 09/07/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 00875800928 continuum longevity contained liner with locking ring, lot#: 62134601 medical records were not provided, however review of the additional information by a healthcare professional identified: blood loss should be minimal for this procedure, coming only from the layers incised.Excessive bleeding occurs when reaming the acetabulum, broaching the femoral canal, or an incidental puncture of a major artery.Per surgical technique guidance, these events would not have occurred.As the patient had multiple contributing factors and comorbidities, the death is not related to zimmer biomet devices.As the devices being replaced would not come in contact with any bone or major vessels that would lead to excessive bleeding, decline, and death.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of reported death in the complaint was determined to not be related to zimmer biomet devices.However, a definitive root cause for the liner not seating intraoperatively cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03616.

Event Description

It was reported that during a revision procedure, the surgeon had difficulty reducing the hip, positioning the locking ring greater than 1 hour, and patient sustained excessive bleeding resulting in multiple blood transfusions.Due to the patient¿s decline, the surgeon aborted the procedure, secured the locking ring and closed the patient.To replace the ringloc and poly liner, the surgeon makes a deep incision exposing the implants and retracts the large vessels and nerves for adequate exposure.The femoral head is dislocated to expose the head and liner.The liner and locking ring are then disengaged and removed.Postop the patient remained unstable and passed away during the night.

• Brand Name: UNKNOWN CONTINUUM SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9907871
• MDR Text Key: 185902623
• Report Number: 0001822565-2020-01211
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 73